Eu Ivdr
Eu Ivd Class B
On The Market
🇺🇸 United States
Aptiva® APS IgM Reagent
Devices (same UDI-DI)
1
Certificates
0
Countries
20
Notified Bodies
0
Basic Information
- Primary DI
- 08430793040853
- Basic UDI-DI Code
- 843079304085345
- Reference
- 725140
- Device Types
-
Single use New device
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Inova Diagnostics. Inc.
Additional Description
The Aptiva APS IgM Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GPI) IgM autoantibodies in human serum and citrated plasma as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings. The Aptiva APS IgM Reagent is intended for use with the Aptiva Multi-Analyte System.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100503 | ANTI-B2-GLYCOPROTEIN I ANTIBODIES |
| W0102100501 | ANTI-CARDIOLIPIN ANTIBODIES |
Available In Countries
🇦🇹 Austria
🇧🇪 Belgium
🇨🇾 Cyprus
🇩🇪 Germany
🇩🇰 Denmark
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇭🇷 Croatia
🇮🇪 Ireland
🇮🇹 Italy
🇱🇮 Liechtenstein
🇱🇺 Luxembourg
🇱🇻 Latvia
🇲🇹 Malta
🇳🇱 Netherlands
🇵🇱 Poland
🇵🇹 Portugal
🇸🇮 Slovenia
🇬🇧 United Kingdom
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